MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthralgia (2355); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six years post initial tka, the surgeon did a revision surgery on the male patient on (b)(6).The patient was suffering from swollen knee and painful knee during exercise.There was no radiological abnormality.Patient had chronic hydroarthritis since one year.A synovectomy was performed and the polyethylene changed.The sales rep was unable to obtain images or x-rays.The device is not available for evaluation due to patient wants to keep it.Additional information received indicates that the metal parts were sealed well.The patella pe was noted to be almost intact, but the tibial pe was worn on both plates.There were no difficulties or unforeseen events encountered.The one-piece synovectomy was completed posteriorly, and the control of joint kinetics was noted to be excellent.The knee was stable, and everything was well aligned with full extension for the 11mm ps insert.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear, which may have been due to malalignment between the implants, high contact stresses during knee flexion, patient-related conditions, instability, or any combination of these possibilities.However, this could not be confirmed as the device was not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d4, h6.The revision reported was likely the result of prosthesis wear, which may have been due to malalignment between the implants, high contact stresses during knee flexion, patient-related conditions, instability, or any combination of these possibilities.However, this could not be confirmed as the device was not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3525541928
• MDR Report Key: 18679898
• Report Number: 1038671-2024-00189
• Device Sequence Number: 20637362
• Product Code: JWH
• UDI-Device Identifier: 10885862173638
• UDI-Public: 10885862173638
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• Device Catalogue Number: 02-012-44-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 05/15/2024; 06/21/2024; 05/08/2025
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 06/21/2024; 06/24/2024; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPOSANT FEMORAL LOGIC A CIMENTER T.4 DROIT.; EMBASE TIBIALE FIT LOGIC CIMENTEE 4F/4T.; ROTULE 3 PLOTS DIAM 38 10MM OPTETRAK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male